510(k) K780439
- Device
- Precimat Glycerol
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K780439
- Product code
- JGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-18
- Date received
- 1978-03-20
- Regulation
- 862.1705
- Classification name
- Fluorometric Method, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017379203
Source Documents#
510(k) summary PDF not indicated by FDA